Grade I/II Ankle Sprain
Conditions
Brief summary
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.
Interventions
DEVICEfirefly
OTHERStandard of care
Sponsors
Firstkind Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years and over 2. Referred to physiotherapy for treatment of ankle sprain 3. Clinical diagnosed ankle sprain with evidence of swelling 4. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form. 5. Able and willing to follow the protocol requirements
Exclusion criteria
1. Has an ankle sprain grade 3 2. Evidence of fracture 3. Has a pacemaker 4. Chronic Obesity (BMI Index \>40kg/m2). 5. Pregnancy. 6. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism. 7. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted 8. Not able to fit firefly device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oedema lower leg | 1 week |
| FAAM ankle function measure | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken | 1 week |
| VAS Pain score | 1 week |
| Adverse event rate | 1 week |
Countries
United Kingdom
Outcome results
None listed